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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrode, Electrocardiograph
510(k) Number K935281
Device Name ARBO H87P, H85P, H27P DISPOSABLE MONITORING ELECTRODES
Applicant
Arbo Medical, Inc.
300 Long Beach Blvd.
Stratford,  CT  06497
Applicant Contact JEFFREY M BLOCK
Correspondent
Arbo Medical, Inc.
300 Long Beach Blvd.
Stratford,  CT  06497
Correspondent Contact JEFFREY M BLOCK
Regulation Number870.2360
Classification Product Code
DRX  
Date Received11/03/1993
Decision Date 09/06/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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